Pharmadrug Inc (CSE:PHRX, OTCQB:LMLLF) has provided an update on multiple activities currently underway which support its 'pipeline-in-a-pill' approach in the development of PD-001 - its patented, orally bioavailable version of cepharanthine for the treatment of cancer and infectious disease.
The company said that following the submission of its Type B pre-IND (investigational new drug application) meeting request and briefing package to the Food and Drug Administration, it received a written response regarding its clinical development plan for PD-001 as a potential oral antiviral pill for COVID-19 and variants of concern.
PharmaDrug said it believes the feedback provides a path to agreements on IND-enabling studies, the design of a Phase 1/2 clinical study, and the overall clinical development plan to move PD-001 forward as an oral treatment for COVID-19.
"We are excited to be efficiently moving our PD-001 program towards a clinical trial. The critical path from a timeline perspective is driven by the GMP production of our drug product and the associated non-clinical testing that will be performed on the product,” said Pharmadrug CEO Daniel Cohen in a statement. “In the meantime, we have identified 3 distinct indications that we believe are of merit for a cepharanthine clinical trial; esophageal cancer, prostate cancer and Covid.”
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By extension, the FDA guidance also provided important insights on advancing PD-001 as a potential treatment for oncology indications as part of the company's ongoing strategy of targeting prostate and esophageal cancers. It remains focused on completing the remaining IND-enabling studies to support its planned clinical studies.
Based on positive feedback from the FDA on the company's proposed Chemistry and Manufacturing Control (CMC) program, PharmaDrug said it has initiated cGMP production at Southwest Research Institute (SwRI) of a quantity of PD-001 expected to be sufficient to support development activities through to the end of Phase II assessment.
The bulk active pharmaceutical ingredient (API) has been received by SwRI and the drug substance, cepharanthine-2HCL, is being manufactured. The completion date is expected to be in the second quarter of 2022.
Following full characterization of the drug substance for critical quality attributes, the drug product manufacturing (enteric coating of the drug substance) will commence, the company said.
The material produced under these tasks will support IND-enabling activities, such as stability, safety, toxicology, pharmacokinetic and non-clinical efficacy studies, required by the FDA prior to proceeding to human clinical studies.
Cohen added: “Our current lead indication continues to be esophageal cancer, based on the ODD status we received from the FDA, the efficacy data and the current unmet need in esophageal cancer. We plan to continue to add to the breadth of all 3 programs as we execute the activities necessary to bring PD-001 to the clinic."
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